Comparative Wockhardt's Glucose Clamp Study-Human Isophane Susp 30IU/ml/70IU/ml With Novolin70/30, in Healthy Subjects

Phase 1

Completed

• Conditions: Diabetes Mellitus
• Interventions: Biological: Novolin 70/30; Biological: 30% Regular Insulin Human Neutral and 70%Isophane Insulin

• Registration Number: NCT01358435
• Lead Sponsor: Wockhardt

Brief Summary

The aim of this trial is to demonstrate bioequivalence of Wosulin 70/30 to Novolin® 70/30 with regard to its total and to its maximum serum insulin concentrations.

Detailed Description

The purpose of this study is is to test for bioequivalence based on AUC0-24h and Cmax between Wosulin 70N/30R and Novolin 70/30.The study also compares the pharmacokinetic and pharmacodynamic profiles as well as assessing safety and local tolerability of the two insulin preparations in healthy subjects.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2011-05-20
• Study First Submitted QC: 2011-05-20
• Study First Posted: 2011-05-23
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-26
• Last Update Posted: 2012-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

1. Healthy male or female subject.
2. Age ≥ 18 and ≤ 45 years.
3. Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
4. Body Mass Index (BMI) between 18.0 and 27.0 kg/m2, inclusive.
5. Non-smoker, defined as no nicotine consumption for at least one year.
6. Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.).

Exclusion Criteria

1. Previous participation in this trial or other clinical trials within the last 30 days.
2. Pregnant, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures (defined as intrauterine device (IUD) that has been in place for at least 3 months, double barrier contraception, sterilization or abstinence, or oral contraceptive pill, which should have been taken without difficulty for at least 3 months, or an approved hormonal implant).
3. Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator. In particular, subjects with elevated liver enzymes (AST or ALT > 2 times the upper limit of normal) or impaired renal function (elevated serum creatinine values above the upper limit of normal) or fasting glucose at screening outside the range of 70-99 mg/dl will not be allowed to enter the trial.
4. Any serious systemic infectious disease during the four weeks prior to the first dose of test drug, as judged by the Investigator.
5. History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, anemia (haemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
6. History of alcohol or drug abuse in the past five years.
7. Any positive test for drugs of abuse and /or alcohol at screening.
8. Hepatitis B or C or HIV positive.
9. Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants.
10. Treatment with any insulin product in the past.
11. Use of non-prescription drugs, except routine vitamins, within 2 weeks prior to the first dose of the test drug. Occasional use of acetaminophen is permitted.
12. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
13. Blood donation of more than 500 ml within the last 12 weeks.
14. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
15. Known or suspected allergy to trial product or related products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Novolin 70/30	Novolin 70/30	Novolin 70/30 is a Recombinant Human Insulin with 70% NPH, Human Insulin Isophane Suspension and 30% Regular, Human Insulin Injection
Wosulin 70/30	30% Regular Insulin Human Neutral and 70%Isophane Insulin	Wosulin 70N /30R is a recombinant Human Insulin with 30 % Regular Insulin Human Neutral and 70% Isophane Insulin, 600 nmol/ml, 100 IU/ml.

Primary Outcome Measures

Name	Time	Method
Mean AUC0-24h and Cmax	Visit 2 and 3

Secondary Outcome Measures

Name	Time	Method
PK endpts: AUC0-4h, AUC0-6h, AUC0-12h, AUC6-12h, AUC6-24h,tmax,and elimination rate constant. PD endpoints: AUCGIR0-4h, AUCGIR0-6h, AUCGIR0-12h,AUCGIR0-24h, AUCGIR6-12h, AUCGIR6-24h, GIRmax and tGIRmax Safety : AEs,haematology,biochem,phy exam	Visit 2,3 and 4

Trial Locations

Locations (1)

Profil Institute for Clinical Research; 🇺🇸 Chula Vista, California, United States